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FDA 510(k)

F&P SleepStyle

K-Number: K173193 · 2018-08-08

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2018-08-08
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

F&P SleepStyle is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2018-08-08 under 510(k) number K173193. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F&P SleepStyle?

F&P SleepStyle is a medical device that received FDA 510(k) clearance on 2018-08-08. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K173193.

When did F&P SleepStyle receive FDA 510(k) clearance?

F&P SleepStyle received FDA 510(k) clearance on 2018-08-08, under 510(k) number K173193.

Who is the listed applicant for F&P SleepStyle?

The FDA 510(k) record lists Fisher & Paykel Healthcare, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for F&P SleepStyle?

The FDA product code for F&P SleepStyle is BZD.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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